Public Health Laboratory

Newborn Screening Information for Families:
Parental Options

You have the right to refuse to have your baby screened by the Minnesota Department of Health (MDH) Newborn Screening Program.

There are life-saving benefits of newborn screening. The risks of not screening your baby are very serious. Without screening, your baby could die or have permanent and severe health problems.

If you refuse newborn screening, you must indicate your refusal in writing on the MDH Parental Refusal of Newborn Screening form. Staff from the birth facility will send a copy of the refusal form to the Newborn Screening Program. The original form should be kept in your child's medical chart with a copy given to you by hospital staff or your birth provider.

The refusal form documents that:

you were told the risks of not screening your baby, and

you accept legal responsibility for any consequences (death or health problems) of not screening your baby.

If you refuse blood spot screening through MDH, you may still receive the health benefits of screening by electing to have screening performed by a private laboratory. The specific disorders screened for by private testing laboratories may vary from those screened for by MDH. Private testing kits must be ordered in advance by the parent and a primary care provider must coordinate testing with the specific private laboratory. Discuss this option with your healthcare provider for more information.

During the 2014 legislative session, the Minnesota legislature made changes to Minnesota's newborn screening law. As a result, retention practices regarding blood spots and blood spot test results are determined by when the blood spots were collected.

Retention of blood spots collected on or after August 1, 2014 and their test results

As of August 1, 2014, the Newborn Screening Program may store blood spots collected on or after August 1, 2014 and their test results indefinitely and may use them for program operations as defined by Minnesota Statute 144.125. Blood spots collected on or after August 1, 2014 and their test results are automatically retained by the program unless a parent or guardian directs MDH to destroy them.

If you are a parent or guardian of a child screened on or after August 1, 2014 and you would like to direct MDH to destroy your child's test results and any remaining blood spots, please complete the Directive to Destroy Newborn Screening Blood Spots and Test Results and/or Hearing Screening Test Results form, which can be downloaded from the Education Materials and Forms page.

Destruction of blood spots collected before August 1, 2014 and their test results

Newborn screening blood spots collected before August 1, 2014 and their test results are destroyed according to the following timelines, unless a parent or guardian gives written consent for their extended storage and use:

MDH destroys blood spots with negative test results within 78 days of the date MDH receives the newborn screening card.

MDH destroys blood spots with positive test results within 24 months and one week of the date MDH receives the newborn screening card.

MDH destroys all test results within 25 months of the last date they are reported.

If your child's blood spots were collected before August 1, 2014, it is not necessary to direct MDH to destroy blood spots and test results according to the above timelines. MDH is required by law to perform the destruction and does so as a matter of routine practice unless parents specifically direct MDH to store blood spots and their test results for a longer period (see Extended Storage section below).

Minnesota Statute 144.966 allows MDH to store hearing screening and rescreening test results up to 18 years from an infant's date of birth.

However, individual families may instruct MDH to discontinue storing hearing screening and rescreening test results earlier. If a parent or guardian instructs MDH to discontinue storing hearing screening and rescreening test results, MDH will destroy the test results within a month of receiving the instruction or within 25 months of receiving the last test result, whichever is later.

If you are a parent or guardian of a child screened for hearing loss and would like to exercise this option, please complete the Directive to Destroy Newborn Screening Blood Spots and Test Results and/or Hearing Screening Test Results form, which can be downloaded from the Education Materials and Forms page.

If your child was screened and her or his blood spots were collected on or after August 1, 2014, you may give written consent allowing the blood spots and test results to be used for public health studies or research not necessarily related to newborn screening.

Allowing the blood spots and test results to be used for research may not have an immediate benefit to your family, but your family and other families may be helped later on by research that develops new ways to diagnose, prevent, or treat disease. In fact, past research has allowed Newborn Screening to grow so the program is able to help significantly more babies today than it did 40 years ago.

Access to blood spots or test results will be granted only to researchers whose public health studies are approved by an ethics committee called an Institutional Review Board (IRB). An IRB assures the protection of all individuals in research projects. Research using newborn screening blood spots or test results will need to be approved by both the MDH IRB and the researcher's institutional IRB. Access to newborn screening blood spots or test results will not be granted to law enforcement, insurance companies, or others unless required by law or a court order.

If you are a parent or guardian and would like to exercise this option, please complete the Parental Consent for Research Use of Newborn Screening Blood Spots and Test Results form, which can be downloaded from the Education Materials and Forms page.

You may revoke the consent at any time by completing the Parental Revocation of Written Consent for Storage and Research Use Newborn Screening Blood Spots and Test Results form, which can be downloaded from the Education Materials and Forms page.

Unless a parent or guardian gives written consent for extended storage and use, the Newborn Screening Program will destroy any remaining blood spots and test results according to the timeline described above for blood spots collected before August 1, 2014 and their test results.

Once destroyed, the blood spots and test results are no longer available from MDH. However, birth providers may retain newborn screening results in your baby's medical record for a longer period of time.

Newborn screening blood spots and test results may be used to help both your family and other families in Minnesota. Leftover blood spots can be valuable in providing a better understanding of the public and personal health issues affecting Minnesota residents.

If stored, your child's blood spots and test results will be available to you in the future for further health-related testing of your child. Blood spots can also be used for identification purposes in the case of a missing or deceased child. Test results can be useful for parents with a child affected by one of the disorders on the newborn screening panel who wish to review their other children's newborn screening results, or for student athletes who need to provide a copy of their sickle cell results to the NCAA (National Collegiate Athletic Association).

If your infant was screened before August 1, 2014, and you authorize MDH to store your infant's blood spots and test results, they may be used for:

studies related to newborn screening, including studies used to develop new tests;

public health studies or research not related to newborn screening; and

public health studies or research with external partners, such as the University of Minnesota or the Mayo Clinic (contingent upon approval by the MDH Institutional Review Board).

When consent is granted, newborn screening blood spots and test results may be used for the purposes described above for up to 18 years. No personal identifying information will be attached to the blood spots or test results if used for research.

If your child's blood spots were collected before August 1, 2014, and you would like to authorize them and their test results to be available for use for these purposes, please complete the Parental Consent for MDH to Store and Use Newborn Screening Blood Spots and Test Results form, which can be downloaded from the Education Materials and Forms page. If you are interested in this option, please note the retention timelines listed above and be sure to submit your consent form before the projected date of destruction of your child's blood spots and results.

You may revoke the consent at any time by completing the Parental Revocation of Written Consent for Storage and Use Newborn Screening Blood Spots and Test Results form.

Parents or guardians may request that their child's newborn screening blood spots be returned to them at any time as long as a Directive to Destroy form has not already been received. To request this option, contact the Minnesota Department of Health Newborn Screening Program. Program staff will discuss with you the process for safely returning specimens to the requesting parents/guardians.